Safety, Tolerability and Pharmacokinetic Profile of Levodopa Administered With Continuous Administration of ND0611

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: Male

Summary

The study hypothesis is that continuous ND0611 increases the bioavailability of levodopa and therefore the levodopa area-under-the-concentration-curve values, half-life, and trough concentrations The study will help determining the safety and tolerability of ND0611 and determine the pharmacokinetic profile of levodopa following multiple oral dosing of levodopa/carbidopa (LD/CD) and continuous delivery of ND0611

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: NeuroDerm Ltd.
• Treatments: Levodopa

Criteria

Inclusion Criteria:

• Healthy Caucasian males between 18 and 50 years (inclusive) of age

• Normal body weight

• Subjects with negative urinary drugs of abuse, HIV, Hepatitis B or Hepatitis C serology tests

• Subjects must be able to adhere to the protocol requirements

• Subjects must provide written informed consent to participate in the study.

• Haemoglobin level >12.5 mg /dl

Exclusion Criteria:

• History of significant psychiatric disorder, neurological diseases or sleep disorders

• History of significant systemic diseases, by medical history or tests performed during screening examinations

• Clinically significant laboratory tests at screening

• History of drug or alcohol abuse.

• Allergy to levodopa, carbidopa or any inactive component of the test formulation.

• Subjects with dark skin

• Subjects with skin diseases or neoplasms

• Subjects with narrow-angle glaucoma

• Subjects with significant allergic response to other drugs.

• Subject with known atopic disorders

• Known allergy or hypersensitivity to adhesive tapes.

• Use of any prescription or over-the-counter (OTC) medications

• Subjects who donated blood or received blood, in the last 3 months

• Participation in another clinical trial in the last 30 days

• Subjects which do not have the ability to communicate well or will not adhere to the protocol procedures